CLINICAL BIOLOGICS MANUFACTURING AND CELL CULTURE (CBMCC) SHARED RESOURCE Timothy Clay, Ph.D., Director The Cancer Center Clinical Biologics Manufacturing and Cell Culture (CBMCC) Shared Resource combines hree elements: (i) the Clinical Biologics Manufacturing Unit for manufacturing under cGMP cellular, tissue, _rotein, antibody, nucleic acid, and viral vector modified biologics for testing in early phase clinical trials; (ii) ihe Non-clinical Cell Culture Unit which is a specialized cell culture service that includes a cell line repository and large scale cell culture capacity for Cancer Center investigators; and (iii) the Supply Unit, a self-supporting reagent supply service for research laboratories within the Cancer Center and campus-wide. The Clinical Biologics Manufacturing Unit is a new addition to this shared resource since the previous review in 1998. By adding this new component to this shared resource, we have greatly increased the scientific merit of the shared resource and established a critical element within the Cancer Center for translating novel therapies from the research bench to early phase clinical trials. The Unit provides a skilled staff with extensive technica!, expertise in clinical biologics manufacturing under strictly regulated, FDA approved protocols and SOP s, who can perform manufacturing for Cancer Center members. Additionally, regulatory submission s to the IRB, FDA, CTEP, and NIH-RAC, and regulatory oversight of manufacturing is also supported within this Unit. The non-clinical Cell Culture Unit provides technical support for the Cancer Center members. In 2003 the Unit provided services to 97 peer-reviewed Cancer Center members in all 11 Cancer Center Programs. Many Cancer Center members rely on this Unit to perform small and large-scale cell culture because they lack the personnel, expertise, or the equipment to perform this task in their own labs. The Supply Unit provides material support for CMBCC technical efforts and for the Cancer Center member's own labs. Its large user base allows it to negotiate excellent price contracts (75% discounts) and pass these savings directly on to Cancer Center members.